jueves, 31 de diciembre de 2015

World leaders at the UN climate talks have just set a landmark goal that can save everything we love!

This is what we marched for, what we signed, called, donated, messaged, and hoped for: a brilliant and massive turning point in human history.It’s called net-zero human emissions -- a balancing of what we release into the air and what is taken out -- and when the dust settles and the Paris Agreement is in the hands of lawmakers, clean energy will be the best, cheapest, and most effective way to keep their promise. This gives us the platform we need to realize the dream of a safe future for generations!

This moment took a movement. In the last weeks, our community has played an extraordinary role to help push through this historic deal. After we smashed global records, marching in the hundreds of thousands all over the globe, we brought our voices into the summit -- literally -- with a chorus of members’ personal messages as delegates entered, Avaaz staff then delivered our petition directly to the UN Secretary-General, kicking off an incredible string of campaigns. (Más)

miércoles, 30 de diciembre de 2015

Indication: Multiple sclerosis (Ph.III) What the clinical trials found: OPERA I and OPERA II studies (Ph.III) met primary endpoint with a nearly 50% reduction in annualized relapse rate over a two-year period. Overall, AEs were similar to interferon beta-1a in both studies; the most common AEs were mild to moderate infusion-related reactions. Credit Suisse Success Probability and inThought Comment: 60%. After 15 years in development with failures in RA and lupus, this Rituxan follow-on compound appears to be a game changer in MS. In addition to being the first drug that really works in primary proressive MS, it's on track to be a serious threat to all the current relapsing remitting MS drugs. Expected launch: 2017 (Source: Credit Suisse) Credit Suisse revenue forecast: $2.23 billion in global annual sales by 2020 What the physicians are saying: Based on positive Phase II and Phase III trial results, some neurologists feel that ocrelizumab's -efficacy profile could eventually top that of Tysabri (natalizumab). What may separate ocrelizumab from other effective marketed brands is its promising positive data in primary progressive MS, a form of the disease currently with no approved treatments. While trial results also show great promise in the much more prevalent form of MS, relapsing-remitting MS, the product's benefit/risk profile may deter neurologists from calling on the agent too early and reserve it only for more progressive cases of the disease. Even if this is the case, it would be neurologists' first approved therapy for these patients. —Paul Wojciak, research director, GfK

ORPHAN

Kyndrisa (drisapersen) BioMarin

Indication: Duchenne muscular dystrophy (Pre-reg.) What the clinical trials found: A Phase III study (DEMAND III) showed a 49m difference in the six-minute walk test (6MWT) between those on continual active treatment (n = 52) and those who had been on placebo for the first 48 weeks followed by active treatment (n = 31). AEs were consistent with previous trials.
Jefferies revenue forecast: $1.06 billion in global sales by 2021
Credit Suisse Success Probability and Jefferies comment: 50%. Despite imperfect data, our due diligence indicates a likely positive outcome (we assume ~75% probability for success). Expected launch: 2016 (Sources: Credit Suisse; Jefferies) What the physicians are saying: There are few treatment options for patients and families affected by Duchenne muscular dystrophy (DMD). The FDA has granted BioMarin's drisapersen priority review status and approval is expected in 2016. [Its PDUFA date is scheduled for 12/27/15. —Ed.] Drisapersen targets exon 51 by “skipping” this genetic code and thereby allowing the creation of partially functional dystrophin, the muscle protein missing in DMD. It is estimated that 13% of DMD's population will benefit from this treatment. It's not a cure, but physicians are expected to welcome this drug into their limited armamentarium as well as Sarepta Therapeutic's eteplirsen, which has a similar mechanism of action. —Joanne French, VP, new products, GfK

martes, 29 de diciembre de 2015

Indication: Asthma/COPD (Ph.III) What the clinical trials found: Patients taking benralizumab vs. placebo in a Phase IIb study saw a significant reduction in asthma exacerbation rate over a one-year period. The study met secondary endpoints with patients experiencing lung function and asthma control improvements as measured by the ACQ-6. Overall, frequencies of AEs were similar for benralizumab and placebo. Common cold and skin reactions at the injection site occurred more frequently with benralizumab than placebo. Credit Suisse Success Probability: 60%. Expected launch: 2017 (Source: Credit Suisse) Credit Suisse revenue forecast: $676 million in annual global sales by 2020 What the analysts are saying: Benralizumab is part of a new era of treatments for severe asthma that will provide benefits we haven't had for uncontrolled patients. With few options other than medium- to high-dose inhaled corticosteroids and LABAs, patients suffer from both the emotional and physical burden of extended symptomatic states and multiple hospital visits due to exacerbations. Additional effective therapies are a high-level unmet need in this market. Primary concerns remain around potential safety concerns and identifying patients who will benefit from treatments. Still, most physicians see the clinical value these new entries offer and are optimistic about future patient outcomes. —Anita Agier, head of Disease Atlas, GfK Healthcare

RevefenacinTheravance Biopharma/Mylan

Indication: COPD (Ph.III) What the clinical trials found: Data from the Phase-IIb study showed a rapid onset of action, with a median time to achieve a clinically relevant improvement in lung function (at least 100mL increase in FEV1) of 30 minutes for doses of 88 mcg and above. TD-4208 (revefenacin) also reduced the need for short-acting inhaled rescue medication in a dose-dependent manner. The agent was generally well tolerated and had AE rates similar to placebo.
Credit Suisse Success Probability: 50%. Expected launch: 2019 (Source: Credit Suisse) Credit Suisse revenue forecast: $225 million in annual global sales by 2020 What the analysts are saying: Communicated as potentially a best-in-class drug and first nebulized LAMA, revefenacin may be desirable for some patient types or by preference. The delivery method is thought to achieve a faster and more effective relief of symptoms. The overall impact on the patient quality of life could be perceptively considerable. However, revefenacin will face the same obstacles as any asset entering into a highly competitive, dynamic and undifferentiated market: What real value will it offer compared to current therapies, and at what price? —Anita Agier, head of Disease Atlas, GfK Healthcare

Selexipag Actelion

Indication: PAH (Pre-reg.) What the clinical trials found: Trial results (Ph. III, GRIPHON) showed a 40% decrease in the risk of a morbidity or mortality event, compared with placebo (p < 0.0001), in patients with pulmonary artery hypertension (PAH). All patients had a significant increase of 12 meters in six-minute walk distance at week 26 (p = 0.0027), with an improvement of 34 meters in PAH-treatment naive patients (p = 0.0002). Overall tolerability of selexipag was consistent with prostacyclin therapies.
Credit Suisse Success Probability: 85%. Expected launch: 2016 (Source: Credit Suisse) Credit Suisse revenue forecast: $982 million in annual global sales by 2020
What the analysts are saying: Selexipag is possibly the most promising new treatment for patients with PAH, a rare and debilitating condition. Its formulation, trial results and novel effects targeting the prostacyclin pathway provide optimism for physicians that patients will be treated more proactively, although the relative effects and long-term outcome benefits compared to current prostacyclin formulations remain a question. —Anita Agier, head of Disease Atlas, GfK Healthcare

domingo, 27 de diciembre de 2015

Whitehead founded Sprout with her husband Bob, who she succeeded as chief executive in January 2015. Under Whitehead’s leadership, Sprout was able to revive Addyi (flibanserin) – a drug that Boehringer and regulators had given up on in 2010 – and obtain US approval for the female libido drug in September, despite questions about its efficacy and safety concerns. Shortly after, Valeant bought the company for $1 billion. Whitehead has 22 years’ experience in healthcare, including roles at Merck & Co, Dura Pharmaceuticals and Elan Pharmaceuticals.

The supposed problem that flibanserin helps women solve is an absence of spontaneous, out-of-nowhere desire. Here's how one participant in the flibanserin drug trials described her difficulty: "Once I started, it wasn't an issue. It was getting me started."

"I hate having to 'wind myself up' to do it," said another participant, "It makes me feel broken."

Like many women, the two flibanserin Guinea pigs were taught to believe that if they don't experience a "craving" sensation, there must be something wrong with them. But that's simply not true.

Research over the last 20 years has found that there is another totally legitimate way to experience desire. It is called responsive desire, because it emerges in response to pleasure, whereas spontaneous desire emerges in anticipation of pleasure. (...)

Spontaneous desire is not an essential component of sexual well-being. Pleasure is an essential component — having fun at the party — and what the research tells us is that responsive desire is not associated with arousal difficulties, problems with orgasm or any other dysfunction.

Most people experience both spontaneous and responsive desire at different times in their lives, though researchers don't have universally accepted numbers of how many people experience either. Responsive desire isn't worse than spontaneous desire, it's just different.

Yet Sprout, the company that owned flibanserin at the time of its approval, appears, shockingly, not to realize that a little "winding up" is perfectly normal, and that it's — therefore — been treating healthy women.

During an FDA hearing, one panelist asked why women in the study were having, on average, two or three "sexually satisfying events" per month before the trial began. If they lacked desire, asked the panelist, why were they having any sex? A Sprout presenter answered, "Once they engage in activity, it's pleasurable."

Indication: Type 2 diabetes (Ph.III) What the clinical trials found: In a Phase-III trial vs. Sanofi's Lantus, lixisenatide/insulin glargine combination met the primary endpoint of statistically superior reduction in HbA1c (LixiLan-L). The Phase III LixiLan-O trial found the fixed-ratio, once-daily injection of lixisenatide/insulin glargine combination superior to both Lantus (insulin glargine) and Sanofi's Lyxumia (lixisenatide) alone in reducing HbA1c. The combination was well-tolerated with few reported AEs. Credit Suisse Success Probability: 50%. Expected launch: 2017 (Source: Credit Suisse) Credit Suisse revenue forecast: $975 million in annual global sales by 2020 What the physicians are saying: Despite new therapy advancements, insulin patients continue to struggle with control. Our data over the past few years have shown an increase in GLP-1 use in combination with insulin, albeit at low levels. Given Lantus's strong standing in the market and the benefits attributable to GLP-1s, physicians will appreciate the convenience of the lixisenatide and Lantus combination. Notably, the addition of a GLP-1 to basal insulin offers the possibility of postprandial control without the risk of weight gain associated with adding a prandial insulin. And, it simplifies the regimen for patients who are already treating several other conditions in addition to diabetes. —Mary McBride, VP, GfK Roper Diabetes

Semaglutide Novo Nordisk

Indication: Type 2 diabetes (Ph.III) What the clinical trials found: The Phase-III SUSTAIN 3 trial showed that once-weekly injection of 1mg semaglutide provided better glycemic control and greater weight loss than 2mg AstraZeneca's Byetta once-weekly. Semaglutide was generally safe and well tolerated. Credit Suisse Success Probability and inThought Comment: 60%. The GLP-1 inhibitors are slowly emerging as having the best efficacy of the pre-insulin diabetes medicines, but there are already similar weekly formulations on the market. Perhaps this one will have a smaller needle or less injection site pain, but more interesting are the various combinations of GLP-1s with insulins or SGLT2 inhibitors. Expected launch: 2017 (Source: Credit Suisse)
Credit Suisse revenue forecast: $878 million in annual global sales by 2020 What the physicians are saying: The GLP-1 market is increasingly crowded, with several once-weekly subcutaneous injection options already on the market. While GLP-1s have been available for more than a decade, uptake has been slow. Where semaglutide will set itself apart is with its oral formulation (O62175C), currently out of Phase II trials. This will appeal to physicians looking to move needle-adverse patients onto a GLP-1. Recent results from SUSTAIN-2 are favorable for semaglutide's subcutaneous formulation, and if the oral formulation performs well on efficacy and safety, physician uptake will follow. —Mary McBride, VP, GfK Roper Diabetes

MK-1293 (insulin glargine biosimilar) Merck/Samsung Bioepis

Indication: Type 1\2 diabetes (Ph.III) What the clinical trials found: In a Phase III study vs. Sanofi's Lantus, the mean change in hemoglobin A1c (A1C) from baseline after 24 weeks is non-inferior in Type 1 diabetes participants treated with MK-1293 (insulin glargine biosimilar). No major safety issues seen. inThought Comment: Biosimilar insulins will be an easier sell to doctors than biosimilars for rheumatoid arthritis or cancer. We expect this to be taken up fairly efficiently, and more importantly, for biosimilar insulins to become cornerstones of diabetes franchises. What the physicians are saying: Merck and Samsung Bioepis's MK-1293 is one of several insulin glargine biosimilars looking to take share from Lantus. While physicians appreciate the cost savings and expanded insulin options biosimilars will provide, the speed with which physicians are ready to move patients to MK-1293 remains to be seen. Uptake will require strong supporting data and a comfort level that transitioning to a biosimilar will be in the patient's interest. A wait and see attitude will prevail among those requiring reassurance that the differences between MK-1293 and Lantus are not clinically meaningful. Uptake will also be linked to MK-1293's ability to obtain interchangeability status with Lantus at the pharmacy. —Mary McBride, VP, GfK Roper Diabetes

martes, 22 de diciembre de 2015

Turing chief executive Martin Shkreli been arrested on a charge of securities fraud relating to a company he founded, Bloomberg reports.

Prosecutors are examining whether the pharma executive illegally took stock during his time at his previous company Retrophin, which he founded in 2011, and used it to pay off personal business debts to hedge fund investors. Shkreli served as chief executive of Retrophin before being ousted from the company and sued by the board in August.

The charges relate to Shkreli’s now-defunct hedge fund, MSMB Capital Management. He is alleged to have engineered transactions between MSMB investors and biotech firm Retrophin, following a trade with Merrill Lynch which cost the hedge fund more than $7 million. Retrophin said the 32-year-old Turing executive paid off as many as 10 investors through fake consulting arrangements and unauthorised appropriations of cash and stock.

Earlier this year, Shkreli called the company's allegations “completely false, untrue at best and defamatory at worst.” He later said the $65 million Retrophin wants “would not dent me.”

Albanian-born Shkreli has hit the headlines numerous times in 2015, beginning with his company's 5000% price-hike on the price of the anti-parasitic treatment Daraprim after Turing acquired the drug earlier this year.

More recently, he was revealed as the $2 million buyer of the only available copy of a new Wu-Tang Clan album, Once Upon a Time in Shaolin. The hip-hop group’s founder, RZA, has since said they were not aware of Shkreli’s business dealings when they made the deal.

Last month, he became chief executive of another pharmaceutical start-up, taking a controlling 70% stake in KaloBios, now the owner of a treatment for another parasitic treatment, benznidazole. The company has since announced plans to substantially raise the price of this drug. While it currently costs around $100 for a month’s supply, KaloBios reportedly intends to increase this to a price structure reflective of those in place in the US for hepatitis C drugs, which can reach as much as $100,000 for a three-month supply.

An estimated 300,000 people in the US have Chagas disease. The third most common parasitic disease worldwide is also known as the ‘kissing bug diease.’

“Schadenfreude.”

Among the general public, the reaction on social media was gleeful.

Peter LaMotte, a consultant who works with pharmaceutical and biotech
companies at the Washington, D.C.-based public relations firm Levick,
said he had never seen more people online use the word “schadenfreude.” (...)

Baum, the chief executive of the compounder that competes with Turing, said he would welcome a political focus on pricing policies.

“I don’t think this is a time to gloat, I don’t think this is a time to be happy,” he said. “It’s really a time for policymakers to buckle down and end these practices.”

The biggest thing pharma companies can do to distance themselves from Shkreli is to be transparent, said LaMotte, the public relations consultant.

“What executives and boards have to do is make sure that their actions cannot be associated in any way with his behavior,” LaMotte said. “They want to make sure that they are taking actions that show … they are ethical players in this industry and for their shareholders.” (Más)

Indication: CV disorders/hypercholesterolemia/hyperlipidemia (Ph.III) What the clinical trials found: Patients with hyperlipidaemia who were on concurrent statin therapy saw significantly reduced LDL-C at week 12 compared with placebo in a Phase II study. The greatest reductions were observed in patients treated with dose regimens of 150mg twice monthly (-52.4 mg/dL) or 300mg once monthly (-44.9 mg/dL). AEs were similar across placebo and treatment groups.
Credit Suisse Success Probability: 52%. Expected launch: 2018 (Source: Credit Suisse) Credit Suisse revenue forecast: $747 M in annual global sales by 2020
What the analysts are saying: Bococizumab will have to fight a battle with established products that have provided real-world experience to physicians. Some believe that bococizumab may be able to achieve “best in class” status within the PCSK9 class through its technological partnership with Halozyme. The company's delivery platform promises to improve the efficacy of individual subcutaneous injections and could reduce the required dose, giving bococizumab an edge over alirocumab and evolocumab, which are also administered subcutaneously. Pfizer, the juggernaut that once ruled the cholesterol management arena with Lipitor, has experience with entering disease areas late. Coupled with a legacy in cardiology, bococizumab shouldn't be counted out. —Alex Bastian, VP, GfK Health

Anacetrapib Merck

Indication: Atherosclerosis/hypercholesterolemia/hyperlipoproteinemia (Ph.III) What the clinical trials found: Anacetrapib decreased LDL-C (from 81 to 45 vs. 82 to 77 mg/dl for placebo; p < 0.001) and increased HDL-C (from 40 to 101 vs. 40 to 46 mg/dl for placebo; p < 0.001) at 24 weeks in patients with CHD or CHD risk-equivalent disease (DEFINE Ph.III) with a good cardio safety profile. Credit Suisse Success Probability and inThought Comment: 60%.The CETP class already has two (well, actually three) strikes, so this is definitely a high-risk/high-reward program. If it works, it'll be HUGE. If it doesn't work, you'll get kicked out of any pharma exec office for even uttering the letters “CETP” for the next 50 years. Expected launch: 2017 (Source: Credit Suisse) Credit Suisse revenue forecast: $2.09 billion in annual global sales by 2020 What the analysts are saying: CETP inhibition has failed three late-stage tests with Eli Lilly throwing in the towel this past year on their investigational agent—following earlier exits from Roche and Pfizer. The failures, however, have added urgency to Merck's development program to look closely at their own outcomes studies. This includes a futility analysis at the end of the 2016 that could provide a quick answer: Move on or move out. Any drug that can address the clinical needs for better HDL cholesterol and improved outcomes could be a mega blockbuster. Of course if it fails, it will be seen as another R&D flop to add to the pile of other CETP inhibitors. —Alex Bastian, VP, GfK Health

Finerenone Bayer

Indication: Congestive heart failure/diabetic nephropathies (Ph.III)
What the clinical trials found: Finerenone was equivalent to eplerenone in reducing a marker of heart failure (NT-PproBNP) and at the optimal dose of 10mg/20mg, there was a 44% reduction in cardiovascular events and mortality. The agent also exhibited signs of a better side-effect profile in the Phase IIb ARTS-HF. Credit Suisse Success Probability: 25%. Expected launch: 2020 (Source: Credit Suisse) Credit Suisse revenue forecast: $117 million in annual global sales by 2020 What the physicians are saying: Many doctors are discouraged from using MRAs, including eplerenone and spironolactone, because of the need for monitoring, and it's estimated that only a third of patients who could benefit from these agents actually receive them. Gerasimos Filippatos, MD, from Athens University Hospital Attikon, Greece, said finerenone has greater selectivity for the mineralocorticoid receptor than spironolactone and greater affinity for the receptor than eplerenone. He noted the agent distributes equally to the heart and the kidney, in contrast to eplerenone, which has been shown to distribute primarily to the kidney. In theory, finerenone should demonstrate potency and safety advantages. —Alex Bastian, VP, GfK Health

domingo, 20 de diciembre de 2015

The Christmas spirit has been a widespread phenomenon for centuries, commonly described as feelings of joy and nostalgia mixed with associations to merriment, gifts, delightful smells, and copious amounts of good food. It is yet to be determined, however, where in the human body this “Christmas spirit” resides and which biological mechanisms are involved. We attempted to localise the Christmas spirit in the human brain using functional magnetic resonance imaging (fMRI).

Results Significant clusters of increased BOLD activation in the sensory motor cortex, the premotor and primary motor cortex, and the parietal lobule (inferior and superior) were found in scans of people who celebrate Christmas with positive associations compared with scans in a group having no Christmas traditions and neutral associations. These cerebral areas have been associated with spirituality, somatic senses, and recognition of facial emotion among many other functions.

Conclusions There is a “Christmas spirit network” in the human brain comprising several cortical areas. This network had a significantly higher activation in a people who celebrate Christmas with positive associations as opposed to a people who have no Christmas traditions and neutral associations. Further research is necessary to understand this and other potential holiday circuits in the brain. Although merry and intriguing, these findings should be interpreted with caution. (Más)

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